Devices and Methods for the Treatment of Endometriosis

ABSTRACT

A tissue treatment device comprises an insertion section sized and shaped for insertion into the body via a trocar and a diagnostic element coupled to the insertion section, the diagnostic element illuminating tissue with light of a wavelength selected to facilitate identification of target tissue in combination with an ultrasound element coupled to the insertion section for delivering to a portion of tissue illuminated by the diagnostic element ultrasound energy.

PRIORITY CLAIM

This invention claims priority to U.S. Provisional Patent ApplicationSer. No. 60/626,033 entitled “Devices and Methods for the Treatment ofEndometriosis” filed Nov. 8, 2004, the disclosure of which isincorporated, in its entirety, herein.

BACKGROUND OF THE INVENTION

The rate of recurrence for endometriosis is high. This is partially dueto difficulties in diagnosing and removing the implanted endometrialtissue.

A first step in localized treatments is the identification ofendometrial lesions on the walls of the peritoneal cavity. Once thelesions have been located, these areas may be treated for removalthereof. For example, heat, electricity, cold, or radiation may bedirected to each of the lesions to necrose the tissue. Alternatively,the tissue may be excised or removed by another mechanism. Theeffectiveness of these methods depends generally on the accuracy of thelocalization of the Lesions and the accuracy with which the therapeutictreatment is provided to those locations.

Blue light (e.g., of approximately 440 nm in wavelength, but that mayrange from 400 to 500 nm) has been shown to be superior to white lightin identifying endometriosis lesions. Current treatments generallyinvolve the insertion of a laparoscope to an operative space (e.g., viaa first trocar) and the insertion into the operative space of a secondtrocar for the introduction of diagnostic and therapeutic tools. Tosupplement the white light source of the vision system of thelaparoscope, a source of diagnostic light (e.g., blue light) is insertedinto the operative space via the second trocar to identify target tissue(e.g., lesions) and to physically mark the locations of this targettissue. The source of diagnostic light is then removed from the secondtrocar and a source of ablation energy (e.g., radio frequency energy,laser energy) is introduced through the second trocar into the operativespace. Energy from the energy source is then directed to the positionsearlier noted for target tissue. It is difficult to apply the treatmentsto the exact locations of the lesions using this method as the bleedingassociated with the current treatments (e.g., laser or RF ablation)interferes with the observation of the target locations. In addition,the time required for these treatments is increased as the diagnosticlight source is withdrawn and the energy source is inserted.

SUMMARY OF THE INVENTION

In one aspect, the present invention is directed to a tissue treatmentdevice comprising an insertion section sized and shaped for insertioninto the body via a trocar and a diagnostic element coupled to theinsertion section, the diagnostic element illuminating tissue with lightof a wavelength selected to facilitate identification of target tissuein combination with an ultrasound element coupled to the insertionsection for delivering ultrasound energy to a portion of tissueilluminated by the diagnostic element.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram showing a first embodiment of a treatment systemaccording to the present invention; and

FIG. 2 is a diagram showing a second embodiment of a treatment systemaccording to the present invention.

DETAILED DESCRIPTION

The present invention may be further understood with reference to thefollowing description and the appended drawings, wherein like elementsare referred to with the same reference numerals. The invention relatesto devices for the treatment of tissue within body spaces or holloworgans and more specifically relates to a system and method forminimally invasively surgically treating endometriosis and otherlesions.

Embodiments of the present invention simplify the treatment of tissue inhollow organs and make these treatments more reliable. An exemplarysystem according to embodiments of the present invention integrates adiagnostic light and an ultrasound energy source into a single toolpermitting a user to accurately identify and treat target tissue undervisual guidance. Thus, the surgeon is able to accurately aim energy fromthe ultrasound source toward each portion of target tissue under visualcontrol while illuminated by the diagnostic light source. According toan exemplary embodiment of the invention, a user may switch back andforth between differing illumination modes (e.g., blue and white light)without removing and re-introducing devices or illumination sources andwithout requiring an additional trocar. In another embodiment, a usermay use both the blue light and the white light at the same time.

Procedures using embodiments of the present invention are no moreinvasive than conventional procedures as the diagnostic light source andthe ultrasound energy source are incorporated into a single tool and noadditional incisions or trocars are required. Furthermore, theultrasound energy delivery device incorporated in the embodiments of thepresent invention minimizes the interference with vision associated withthe bleeding caused by other treatment methods and makes it possible tomaintain the target tissue under visual observation with either blue orwhite light during tissue treatment. It will be apparent to those ofskill in the art that the exemplary surgical device may be used forother procedures in addition to the treatment of endometriosis. Forexample, interstitial cystitis may also benefit from a treatmentutilizing a tool including a light source and an ultrasound energydelivery device as will be described in more detail below.

As shown in FIG. 1 a system 100 according to an exemplary embodiment ofthe invention includes an integrated diagnostic and therapeutichandpiece 102 including apparatus for identifying and treating targettissue (e.g., lesions) within a body space or cavity. For example, thetreatment may include subjecting target tissue to ultrasound energy to,for example, ablate the tissue. A control unit 104 contains remotecomponents of the diagnostic and ultrasound devices, For example,generators and electronic controls too large or otherwise unsuitable forlocation in the handpiece 102 are preferably housed in the control unit104. A conventional laparoscope 116 containing a vision tool 118including a source of white light and a conventional light gatheringapparatus is used to provide a view of the handpiece 102 during theprocedure to aid the user in guiding and positioning the handpiece 102.Typically, the laparoscope 116 is inserted into the body space 140 via asecond incision, or through a trocar. Those skilled in the art willunderstand that, for certain procedures, a flexible endoscope may besubstituted for the laparoscope 116 and that the flexible endoscope maybe inserted into the hollow organ via an incision or through a naturallyoccurring body orifice.

In one embodiment, the handpiece 102 is formed as a disposable elementincluding only those components necessary to illuminate and deliverultrasound energy to the target tissue. For example, a light guide suchas an optic fiber may be used to convey light from a light sourcelocated within the control unit 104 to an illumination element 108. Theultrasound component 110 is mounted to the insertion element 120 so thatit may be placed against tissue at which light from the illuminationelement 108 is aimed to directly transfer ultrasound energy thereto. Forsuch a disposable item, the more expensive components of the system 100,for example, the light source 112 and an ultrasound controller 114 arepreferably located in the control unit 104 which is not disposable.

The handpiece 102 preferably comprises a component 106 ergonomicallyshaped to facilitate grasping and manipulation by a user. An insertionelement 120 of the handpiece 102 is adapted for insertion into a bodyspace 140, for example, through the abdominal wall 142. The body space140 may, for example, be a hollow organ or space such as the peritonealcavity. In the exemplary embodiment, the handpiece 102 comprises anillumination element 108 directing light toward a target area to assistin identifying lesions on the wall of the hollow organ. The handpiece102 also includes an ultrasound component 110 directing ultrasoundenergy to the target area illuminated by the illumination element 108.

The illumination element 108 includes, for example, a light guide suchas an optic fiber extending along the length of the handpiece 102 andoperatively connected to a light source 112 located within control unit104. The light source 112 may, for example, be a low power bulb, diode,or other conventional surgical source of illumination. The frequency ofthe light emitted is preferably selected to facilitate the diagnosticprocedure for the particular type of target tissue being treated. Forexample, blue light, for example in the wavelength range of about 440 nmhas been found to be suitable where the target tissue is endometriosislesions. Those skilled in the art will understand that a control unitthat includes the ability to change light spectrum on command (e.g.,blue light to white light) in addition to delivering therapeutic energymay also be advantageous. This may be done in any number of waysincluding using a source of white light for the light source 112 andmoving a filter in and out of a path of the light, switching between theillumination element 108 and an illumination element of the laparoscope116, endoscope, etc. or by incorporating at the distal end of theinsertion element 120 a separate white light illumination elementcoupled to a separate light source.

The ultrasound component 110 which is, for example, a single, smalldiameter ultrasound crystal mounted on a distal end of the insertionelement 120 is vibrated under control of the ultrasound controller 114as would be understood by those skilled in the art to generateultrasound energy of a desired frequency to tissue against which it isabutted. The ultrasound controller may for example comprise amicroprocessor or other computing device controlling signals output froma power source to vibrate an ultrasonic crystal at a desired frequencyand amplitude as would be understood by those skilled in the art. Theultrasound component 110 is preferably an ultrasound crystal 10 mm orless in diameter and, more preferably, 8 mm or less in diameter so thatthe insertion element 120 may be inserted through trocars of as littleas 10 mm I.D. Alternatively, the ultrasound component 110 may include anarray of ultrasound crystals and may further include an ultrasound domedisposed over the ultrasound component 110 and filled with a couplingmedium (e.g., water) allowing ultrasonic waves to propagate therethroughto the lesion when the ultrasound dome is pressed thereagainst. As wouldbe understood by those skilled in the art, the level of ultrasoundenergy delivered to a lesion may be determined as a function of powersupplied to the ultrasound component 110 and/or a time for which theultrasound component 110 is in contact with the lesion.

As little or no bleeding occurs during this ultrasound ablation, theuser is able to immediately move to another lesion after a desireddegree of treatment of a first lesion has been achieved. In this case,the energy supply to the ultrasound component 110 is suspended, the handpiece 102 is moved to separate the ultrasound component 110 from thefirst lesion and, under visual guidance using, for example, the bluelight from the illumination element 108, the ultrasound component 110 ismoved into contact with a second lesion and the process is repeateduntil all the lesions have been treated to the desired degree.

According to exemplary embodiments of the invention, low powerdiagnostic light from the illumination element 108 is used to illuminatea target portion of tissue to assist the user in aiming the ultrasoundcomponent 110. Accordingly, the low power light and the ultrasoundenergy are aimed so that they converge on the same target spot allowingthe user to aim the ultrasound energy on the tissue to be treated. Thatis, the target spot illuminated by the illumination element 108 is thesame as or substantially aligned with the target spot that theultrasound energy will be incident upon when the ultrasound component110 is pressed to the tissue. The illumination element 108 preferablyilluminates an area larger than that on which the energy from theultrasound component 110 is focused with the ultrasound energy focused,for example, at a center of the spot illuminated by the illuminationelement 108. Thus, the user may identify a lesion and immediately treatthe lesion by merely switching on the ultrasound component 110 with noreconfiguration of the hardware required. As described above, since boththe illumination element 108 and the ultrasound component 110 areintegrated in the handpiece 102, the procedure remains minimallyinvasive requiring only two incisions.

As shown in FIG. 2, a system 300 according to a second embodiment of thepresent invention includes an array of ultrasonic crystals 308 focusingultrasonic energy on a target lesion illuminated by a diagnosticcomponent 312 receiving light from a light source 310. For example, anultrasound control unit 302 is operatively connected to a distal portionof the handpiece 304 with an ultrasound dome 306 disposed at the distaltip of the handpiece 304 containing the array of ultrasound crystals308. As would be understood by those skilled in the art, energy fromthese crystals 308 may be focused on a specific spot based on operatingcommands from the control unit 302 by, for example, controlling thefrequency, phase and intensity of the signals from the various crystals308 to shape and focus the sound beam as desired. Alternatively, energyfrom the crystals 308 may be focused on a specific spot by simplyarranging the crystals 308 along a curved surface having a focus area(e.g., a focus point or path) within an area illuminated by thediagnostic component 312. The light source 310 which preferably produceswhite and/or blue light, is connected operatively to the diagnosticcomponent 312 to illuminate the target portion of tissue.

In one exemplary embodiment, the handpiece 102 has a diameter of lessthan 9 mm and is more preferably less than 5 mm in diameter tofacilitate insertion into a hollow organ or other body space through afirst trocar of, for example, 5 mm or 10 mm diameter. Furthermore, thesystem according to the invention is preferably designed for use inlaparoscopic procedures where a laparoscope is inserted into the bodythrough a second trocar of, for example, of 5 mm or 10 mm diameter.

The present invention has been described with reference to specificembodiments, and more specifically to an endometrial treatment system.However, other embodiments may be devised that are applicable to othermedical procedures, and which utilize other sources of therapeuticenergy, without departing from the scope of the invention. Accordingly,various modifications and changes may be made to the embodiments,without departing from the broadest spirit and scope of the presentinvention as set forth in the claims that follow. The specification anddrawings are accordingly to be regarded in an illustrative rather thanrestrictive sense.

1.-20. (canceled)
 21. A tissue treatment device, comprising: aninsertion section sized and shaped for insertion into a body; adiagnostic element coupled to the insertion section, the diagnosticelement configured to illuminate a target area with a first light of afirst wavelength and a second light of a second wavelength selected tofacilitate identification of a select portion of a target tissue; and anultrasound element coupled to the insertion section, the ultrasoundelement including a generating component that generates ultrasoundenergy for delivery to the select portion of the target tissue, whereinthe diagnostic element and the ultrasound element are positioned andoriented within the insertion section such that the second light fromthe diagnostic element and the ultrasound energy from the generatingcomponent converge on a target spot.
 22. The device according to claim21, further comprising a control unit coupled to the diagnostic elementand the ultrasound element, the control unit remaining outside the bodywhile the insertion section is inserted into the body.
 23. The deviceaccording to claim 22, wherein the ultrasound element is coupled to anultrasound controller located in the control unit.
 24. The deviceaccording to claim 23, wherein the diagnostic element comprises a firstilluminating component configured to generate the first light and asecond illuminating component configured to generate the second light.25. The device according to claim 24, wherein the first and secondilluminating components is one of a low-power bulb and a diode.
 26. Thedevice according to claim 21, wherein the first light is a white lightand the second light is a blue light.
 27. The device according to claim21, wherein the generating component includes at least one ultrasoniccrystal.
 28. The device according to claim 21, wherein the target spotis at a center of the select portion of the target tissue illuminated bythe first light.
 29. The device according to claim 21, wherein thegenerating component is exposed to an exterior of the ultrasound elementsuch that the generating component is positioned against the targetportion for direct delivery of the ultrasound energy.
 30. The deviceaccording to claim 29, wherein the generating component is activatedupon an identification of a lesion within the target spot.
 31. A methodfor tissue treatment, comprising: inserting into a body space anendoscopic element; illuminating tissue with a first light of a firstwavelength and a second light of a second wavelength selected tofacilitate identification of a first target portion of tissue via anintegrated illumination element of the endoscopic element; andgenerating ultrasound energy for delivery to the first target portionvia an integrated generating component of the endoscopic element,wherein the illumination element and the generating component arepositioned within the endoscopic element such that the light from theillumination element and the ultrasound energy from the generatingcomponent converge on a target spot.
 32. The method according to claim31, wherein the second light of the illumination element illuminates thefirst target portion of the tissue as the generating component is movedinto contact with the first target portion.
 33. The method according toclaim 32, further comprising: delivering the ultrasound energy to thefirst target portion while the generating component contacts the firsttarget portion; and upon completion of the delivery of the ultrasoundenergy to the first target portion, moving the generating component awayfrom the first target portion to contact a second target portion whileilluminating the second target portion with the second light of theillumination element.
 34. The method according to claim 31, wherein thetarget spot is at a center of a target area illuminated by the firstlight of the illumination element.
 35. The method according to claim 31,wherein the generating component is exposed to an exterior of theultrasound element such that the generating component is positionedagainst the target tissue for direct delivery of the ultrasound energy.36. The method according to, claim 31, wherein the illumination elementcomprises a first illuminating component configured to generate thefirst light and a second illuminating component configured to generatethe second light.
 37. The method according to claim 31, wherein thefirst light is a white light and the second light is a blue light. 38.The method according to claim 31, wherein the generating componentincludes at least one ultrasonic crystal.
 39. The method according toclaim 38, wherein the at least one ultrasonic crystal is an array ofultrasonic crystals arranged along a curved surface of the generatingcomponent.
 40. The method according to claim 39, wherein the curvedsurface has a focus area on the target spot.